Prevention of infectious disease using vaccines has been in practice since the late 1700s (smallpox vaccine of 1798), including use of vaccines for prevention of polio, hepatitis B, and influenza. More recently, vaccines have also been identified for use in treatment of cancer, where the vaccine coaxes the patient's immune system into identifying and destroying target tumor cells, i.e., treatment of breast cancer, colon cancer, skin cancer, etc. Other new and useful targets for vaccine treatment are being developed due to the advantage of using a patient's own immune system to defeat the invading or cancerous agent. In most instances, a vaccine combines an antigen against which the immunity is sought and an adjuvant to enhance the response to that antigen by the recipient of the vaccine.
Growth hormone is a 191 amino acid polypeptide hormone synthesized and released from the anterior pituitary gland. Growth hormone is generally considered an anabolic hormone, required for growth/height in children, increase in calcium retention (bone strength), promotion of lipolysis, increase in protein synthesis, promotion of gluconeogenesis in the liver and other like functions. Patients who suffer from endogenous growth hormone deficiency often have poor bone density, diminished lean body mass, reduced energy, and other like general symptoms.
Presently, patients suffering from growth hormone deficiency are treated with growth hormone replacement, typically using a recombinant growth hormone expressed in genetically engineered bacteria. These treatment protocols are typically extremely costly (estimates range from $10,000 to $30,000 a year) and rely on exogenous replacement of the hormone (daily injections are typical, often spanning 18 months to the lifetime of the patient). As a result, novel, non-exogenous, long-acting, and less costly therapies are required for patients suffering from growth hormone deficiency.
In addition, therapies are also needed to treat patients in need of additional, above baseline levels, of growth hormone, for example these patients often require additional growth hormone for the treatment of obesity, wound healing, burn healing, etc.
The present invention is directed toward overcoming one or more of the problems discussed above.